DeliriumPhase 4NCT01353378
Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium
A Phase 4 study testing dexmedetomidine in people with Delirium, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preschool children undergoing oral maxillofacial surgery
Who cannot join
- mental diseases
- history of neural system disease
- sedative medication history
- anticipated difficult airway
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200011
About this study
The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.
Read the detailed description
Emergence delirium is a common side effect of sevoflurane anesthesia in children. Dexmedetomidine, because of its sedative and analgesic properties, might be useful for the management of this adverse effect. In the pediatric population, it has been shown to provide sedation for magnetic resonance imaging. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intravenously might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing oral maxillofacial surgery.
- Conditions
- Delirium
- Being tested
- dexmedetomidine
- Keywords
- dexmedetomidine, emergence delirium, sevoflurane anesthesia, preschool children, oral maxillofacial surgery
- Medical subject headings
- Delirium, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
Also called dexmedetomidine hydrochloride injection
Intravenously injecting 0.125microgram/kg for 10ml IV(in the vein)in group 1, 0.25microgram/kg for 10ml in group 2 within 10 minutes as soon as the operation begin. The control group receives 10mlsaline in 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | intravenously injecting 0.125microgram/kg and 0.25microgram/kg within 10 minutes as soon as the operation begins respectively. Receives: Drug: dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
post anesthesia emergence delirium scale(PAED scale)
evaluate children's PAED scale score 2 hours post-surgery
Measured: 2 hours post-surgery
Secondary outcomes (1)
Children's Hospital of Eastern Ontario Pain Scale(CHEOP scale)
evaluate children's CHEOP scale score 2 hours post-surgery
Measured: 2 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: The study was not approved by Hospital's Medical Ethics Committee.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Hu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Hong Jiang, MD, PHD, Study director, Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of MedicineRong Hu, MD, Principal investigator, Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353378
- Sponsor's protocol ID
- JYMZK-001
- Status last verified
- May 2017
- First submitted
- 21 Apr 2011
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dexmedetomidine in Children Undergoing Oral Maxillofacial Surgery to Decrease Emergence Delirium
- ClinicalTrials.gov ID
- NCT01353378
- Acronym / sponsor ID
- JYMZK-001
- Conditions
- Delirium
- Keywords
- dexmedetomidine, emergence delirium, sevoflurane anesthesia, preschool children, oral maxillofacial surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not approved by Hospital's Medical Ethics Committee.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 13 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether dexmedetomidine is effective in the treatment of emergence delirium of preschool children undergoing oral maxillofacial surgery.
Detailed description
Emergence delirium is a common side effect of sevoflurane anesthesia in children. Dexmedetomidine, because of its sedative and analgesic properties, might be useful for the management of this adverse effect. In the pediatric population, it has been shown to provide sedation for magnetic resonance imaging. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intravenously might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing oral maxillofacial surgery.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: dexmedetomidineintravenously injecting 0.125microgram/kg and 0.25microgram/kg within 10 minutes as soon as the operation begins respectively. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preschool children undergoing oral maxillofacial surgery
Key exclusion criteria (4 listed)
- mental diseases
- history of neural system disease
- sedative medication history
- anticipated difficult airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexmedetomidineAlso: dexmedetomidine hydrochloride injectionIntravenously injecting 0.125microgram/kg for 10ml IV(in the vein)in group 1, 0.25microgram/kg for 10ml in group 2 within 10 minutes as soon as the operation begin. The control group receives 10mlsaline in 10 minutes. | Drug | dexmedetomidine |
Primary outcome
post anesthesia emergence delirium scale(PAED scale)
Time frame: 2 hours post-surgery
evaluate children's PAED scale score 2 hours post-surgery
1 secondary outcome
Children's Hospital of Eastern Ontario Pain Scale(CHEOP scale)
Time frame: 2 hours post-surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
Related trials for Delirium
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Dementia, Postoperative Delirium (POD)
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Jiang, MD, PHD study director
Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Rong Hu, MD principal investigator
Department of Anesthesiology, Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine in people with Delirium, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post anesthesia emergence delirium scale(PAED scale) (time frame: 2 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.